Food SecurityNCT02789215
Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
A study testing Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs in people with Food Security, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Child and Adult Care Food Program (CACFP) meals are an important influence on diets of children from low-income families enrolled in the CACFP and should meet children's nutrient needs while fostering healthy eating habits that enable them to maintain energy balance. Read more about this study
- Who is it for?
- Ages 3 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Security
- What is being tested?
- Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be day care sites
- Must be parents of children attending the day care sites
Who cannot join
- Parents of children not attending one of the 32 day care sites
Trial locations and contacts
1 site in 1 country.
About this study
Child and Adult Care Food Program (CACFP) meals are an important influence on diets of children from low-income families enrolled in the CACFP and should meet children's nutrient needs while fostering healthy eating habits that enable them to maintain energy balance. Recent national data revealed that children consumed low intakes of foods that support healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of Medicine (IOM) report for CACFP meals provided new recommendations that include new meal pattern requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure that the meals promote health and reduce inadequate and excessive intakes. The report recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives which will likely increase meal costs. Two of the IOM report recommendations call for research to better understand how the new meal requirements would change children's CACFP meal dietary intakes and food service costs. These are important questions, and answers are needed to inform policy and future technical and educational assistance needs. The overall objective of this project is to implement the IOM meal pattern requirements for CACFP meals in day homes and centers in Texas. The multidisciplinary team will focus on nutrition, economics, and provider outcomes. The specific aims are to assess the impact of the new meal pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food, labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It is hypothesized that, compared with control sites, intervention site children will select and consume healthier diets (more fruit, vegetables and whole grains) at school. A total of 32 day care sites will be recruited for the study. It is hypothesized that, compared with control sites, children at the intervention sites will select and consume healthier diets (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the increase in food costs will be less than that projected in the IOM report. The results on the costs associated with creating the desired meals will be very important as these data have not been systematically collected in previous studies. This significant study targets underserved minority populations with health promoting intervention to reduce health disparities, and in addition, will inform policy on the influence of a healthy food environment on children's diet, as well as provide critical information on costs.
- Conditions
- Food Security
- Being tested
- Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
- Keywords
- Child care food costs, Meal participation rates, Child and Adult Care Food Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proposed Meal Changes for CACFP: Impact on Child Food Intake and CostsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive new CACFP menu pattern Receives: Behavioral: Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs |
| Control | No intervention | Follow existing CACFP menu pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Child Dietary Intake at 6 months and 12 months
Measured: Up to 12 months
Change from Baseline Meal Participation Rates at 6 months and 12 months
Measured: Up to 12 months
Change from Baseline Provider Food Service Costs (food, labor, total meals) at 6 months and 12 months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2017
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food SecurityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jayna Dave, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789215
- Sponsor's protocol ID
- H-35784
- Other IDs
- R01HL119520
- Status last verified
- Jan 2020
- First submitted
- 25 May 2016
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The Baylor College of Medicine understands and agrees to comply with the NIH policy on Sharing Research Data and on Sharing Model Organisms (as outlined in the NIH Guide, February 26, 2003 and May 7, 2004.) The principal investigator and co-investigators acknowledge their willingness to share data and materials with other eligible investigators through academically established means. Data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings. Finally, data will be presented by publication to the widest audience possible. Press interviews on important publications are arranged through the Baylor College of Medicine Office of Public Affairs.
Publications
Dave JM, Cullen KW. Foods Served in Child Care Facilities Participating in the Child and Adult Care Food Program: Menu Match and Agreement with the New Meal Patterns and Best Practices. J Nutr Educ Behav. 2018 Jun;50(6):582-588. doi: 10.1016/j.jneb.2018.01.010. Epub 2018 Feb 21.
PubMed 29475767
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
- ClinicalTrials.gov ID
- NCT02789215
- Acronym / sponsor ID
- H-35784
- Conditions
- Food Security
- Keywords
- Child care food costs, Meal participation rates, Child and Adult Care Food Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Child and Adult Care Food Program (CACFP) meals are an important influence on diets of children from low-income families enrolled in the CACFP and should meet children's nutrient needs while fostering healthy eating habits that enable them to maintain energy balance. Recent national data revealed that children consumed low intakes of foods that support healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of Medicine (IOM) report for CACFP meals provided new recommendations that include new meal pattern requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure that the meals promote health and reduce inadequate and excessive intakes. The report recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives which will likely increase meal costs. Two of the IOM report recommendations call for research to better understand how the new meal requirements would change children's CACFP meal dietary intakes and food service costs. These are important questions, and answers are needed to inform policy and future technical and educational assistance needs. The overall objective of this project is to implement the IOM meal pattern requirements for CACFP meals in day homes and centers in Texas. The multidisciplinary team will focus on nutrition, economics, and provider outcomes. The specific aims are to assess the impact of the new meal pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food, labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It is hypothesized that, compared with control sites, intervention site children will select and consume healthier diets (more fruit, vegetables and whole grains) at school. A total of 32 day care sites will be recruited for the study. It is hypothesized that, compared with control sites, children at the intervention sites will select and consume healthier diets (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the increase in food costs will be less than that projected in the IOM report. The results on the costs associated with creating the desired meals will be very important as these data have not been systematically collected in previous studies. This significant study targets underserved minority populations with health promoting intervention to reduce health disparities, and in addition, will inform policy on the influence of a healthy food environment on children's diet, as well as provide critical information on costs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Proposed Meal Changes for CACFP: Impact on Child Food Intake and CostsReceive new CACFP menu pattern |
| Control | No intervention | –Follow existing CACFP menu pattern |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be day care sites
- Must be parents of children attending the day care sites
Key exclusion criteria (1 listed)
- Parents of children not attending one of the 32 day care sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs | Behavioural | Intervention |
Primary outcome
Change from Baseline Child Dietary Intake at 6 months and 12 months
Time frame: Up to 12 months
Change from Baseline Meal Participation Rates at 6 months and 12 months
Time frame: Up to 12 months
Change from Baseline Provider Food Service Costs (food, labor, total meals) at 6 months and 12 months
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Results publication: PubMed 29475767Dave JM, Cullen KW. Foods Served in Child Care Facilities Participating in the Child and Adult Care Food Program: Menu Match and Agreement with the New Meal Patterns and Best Practices. J Nutr Educ Behav. 2018 Jun;50(6):582-588. doi: 10.1016/j.jneb.2018.01.010. Epub 2018 Feb 21.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Baylor College of Medicine understands and agrees to comply with the NIH policy on Sharing Research Data and on Sharing Model Organisms (as outlined in the NIH Guide, February 26, 2003 and May 7, 2004.) The principal investigator and co-investigators acknowledge their willingness to share data and materials with other eligible investigators through academically established means. Data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings. Finally, data will be presented by publication to the widest audience possible. Press interviews on important publications are arranged through the Baylor College of Medicine Office of Public Affairs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs in people with Food Security, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Child Dietary Intake at 6 months and 12 months (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.